New Record-keeping System was Launched for First Imported Non-special Use Cosmetics in Shanghai Pudong New Area

On 17 Jan, 2017, CFDA and AQSIQ jointly issued a Notice regarding Pilot Implementation of Record-keeping for Imported Non-special Use Cosmetics in Shanghai Pudong New Area (Notice No.7.2017). It means from 1 Mar, 2017 to 21 Dec, 2018, the regulatory regime of first imported non-special use cosmetics in Shanghai Pudong New Area will change to record-keeping from current registration. On 18 Jan, 2017, CFDA issued a Notice on Work Program of Record-keeping for Imported Non-special Use Cosmetics in Pudong New Area (Temporary, Notice No.10, 2017). The document covers the main procedures of record-keeping and documents requirements.

Background 

On 19 Apr., 2016, the State Council issued a Decision regarding Temporary Adjustment of Administrative Regulations and Approval Matters Stipulated on State Council Documents in Shanghai Pudong New Area (State Council No. 24, 2016), pointing out that there will be 11 temporarily adjusted administrative regulations and approval matters stipulated on State Council Documents from now until 21 Dec., 2018 in Shanghai Pudong New Area. This decision involves 6 issues, such as drug advertising, radioactive drugs, cosmetics, etc.

Flowchart of regulatory compliance for the first import of non-special use cosmetics in difference cases in 2017

Case 1: the products are imported from the Shanghai Pudong New Area, and the responsible person is registered in Pudong New Area (Shanghai FDA record-keeping)

Case 2: the products are imported from any other ports except Pudong New Area (CFDA registration)


Case 3: the products recorded in Shanghai FDA are no longer to be imported from Pudong New Area

Case 4: the products are imported from Pudong New Area and other ports.


It can be seen that there are different options for enterprises to choose the pre-market record-keeping or registration of imported non special use cosmetics based on actual situations. Meanwhile it is the same for special use cosmetics to be approved by CFDA. The following table summarizes the different ways of record-keeping or registration in terms of type of products, the port of entry, and the characteristics of enterprises.

Product Type

Import Port

Registering a company in Pudong or not

Sales model

Market access program

Imported non-special use cosmetics

Pudong New Area

YES

Offline

Record-keeping in Shanghai FDA

Imported non-special use cosmetics

Pudong New Area and others

NO

Offline

Registration in CFDA

Imported non-special use cosmetics

Pudong New Area and others

YES

Offline

Option 1: Record-keeping in Shanghai FDA at first. Then cancelling the record-keeping in Shanghai FDA before CFDA registration. Finally applying for CFDA registration.

Option 2: Registration in CFDA

Imported special use cosmetics

-

-

Offline

Registration in CFDA

Domestic special use cosmetics

-

-

Offline

Registration in CFDA

Domestic non special use cosmetics

-

-

Offline

Record-keeping in local FDA

Import cosmetic

-

-

Online

CFDA registration is not required for 10 pilot cities such as Tianjin, Shanghai, Hangzhou, Ningbo, Zhengzhou, Guangzhou, Shenzhen, Chongqin, Fuzhou, Pingtan etc before 31 Dec 2017.

Comparisons of the two ways of importing non special use cosmetics to China

Item

Registration in CFDA

Record-keeping in Shanghai FDA

Competent department

CFDA

Shanghai FDA

Authorized application

Chinese responsible person

Chinese responsible person

Requirements of responsible person

No restriction except legal entity

Registered in Pudong New Area

Responsibilities of responsible person

Application of administrative license

Import and operation, product quality and safety

Application scope

All the ports of the country

Pudong New Area in Shanghai

Required documents

Almost the same

Format review

organization

Acceptance Center of CFDA

Shanghai FDA

Technical review

After the formal review, transferring to CFDA Health Food Review Center for technical review

Within 3 months after record-keeping

Issue of CFDA license or Record-keeping certificate

Issued after passing both format and technical review

Automatically generating electronic version of record number after format review for the enterprise to download and print

Format of license or certificate number

国妆备进字J+ year number +4 digits

国妆网备进字(沪)+ year number +6 digits

Term of validity

4 years

Undetermined

No longer importing recorded or registered products

No requirements

Cancellation of record-keeping information

CIRS comments

  1. As is shown in the table, the biggest difference between CFDA registration and the record-keeping in Shanghai FDA is the process and the requirements of the responsible person.
  2. The biggest advantage of record-keeping in Shanghai FDA is that the products can be imported for sale after format review, while CFDA requests to pass the format and technical review before the issuance of CFDA license. This is good news for enterprise in demands of rapid time-to-market.
  3. The documents for CFDA registration or Shanghai record-keeping are almost the same.
  4. More responsibilities are required to the responsible person for the record-keeping in Shanghai FDA compared with the CFDA registration. The responsible person registered in Pudong New Area shall bear the responsibility of product quality and safety.

If you have any questions, please contact us at service@cirs-reach.com.


Source: http://www.sda.gov.cn/WS01/CL0087/168637.html